MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM

Model Number	8700-0650-01-66
Medical Device Problem Codes	Insufficient Heating (1287); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The thermogard xp console (s/n (b)(4)) was not returned to zoll for evaluation, and service personnel did not conduct an on-site investigation.However, zoll service personnel reviewed the system event log files.No alerts or system error codes were noted, suggesting that the console was functioning as intended.
Event or Problem Description
A thermogard xp console (s/n (b)(4)) and a quattro catheter (lot # 155467) were used to provide ivtm treatment to a patient who needed post cardiac arrest care.The catheter was inserted into the patient's left femoral vein with no unusual resistance noted, and a radial arterial line was also placed for medical purposes.The dwell time of the catheter had been approximately 26 hours when the hypothermia phase ended, and the rewarming phase started.Before the initiation of rewarming, the patient's body temperature was measured at 36 °c.The target temperature was set to 37°c, and the console was set to a controlled rewarming rate of 0.2°c/hour.About 15 hours into the rewarming phase of the treatment, it was noticed that the patient was not appropriately warming, which prompted troubleshooting of the thermogard system.The patient's body temperature was at 36.7 °c when the issue was noted.Upon further visual inspection, the customer noted that the tubing of the start-up-kit (suk) (lot # unknown) was bulging in the area around the roller pump, preventing the pump rotor from turning.The nurses replaced the 500-ml saline bag to troubleshoot the issue; however, the suk tubing was still bulging.Subsequently, the customer stopped the ivtm therapy, and an alternative method was used to complete the rewarming treatment.Following treatment, the catheter was removed from the patient easily, and the thermogard console was placed back in clinical use.After the catheter was removed, the nurses injected saline into the catheter to check balloon inflation.When saline was injected into the in-luer, the customer noted that blood was coming out of the out-luer.The customer suspected that the catheter might have possibly leaked during the treatment.No alarms were reported to have been triggered by the thermogard console.It is unknown if any saline was infused into the patient's bloodstream.No further information was provided by the customer.No consequences or impact to the patient.Please see the following related mfr report: mfr # 3010617000-2021-00445 for the quattro catheter (lot # 155467).

• Brand Name: ZOLL IVTM THERMOGARD XP
• Common Device Name: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11905507
• Report Number: 3010617000-2021-00469
• Device Sequence Number: 11862933
• Product Code: NCX
• UDI-Device Identifier: 00849111075565
• UDI-Public: 00849111075565
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8700-0650-01-66
• Device Catalogue Number: 8700-0650-01-66
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1